FDA Approves Abilify Maintena for Bipolar I Disorder Monotherapy Treatment

injection in arm
injection in arm
New bipolar I disorder treatment Abilify Maintena is only required once a month.

Otsuka Pharmaceutical Co., Ltd., and H. Lundbeck A/S announced that the US Food and Drug Administration (FDA) has approved Abilify Maintena (aripiprazole) extended-release injectable suspension for the maintenance monotherapy treatment of bipolar I disorder (BP-I) in adults.

A 52-week, double-blind, placebo-controlled phase 3 study in adults with BP-I between the ages of 18 and 65 years confirmed that Abilify Maintena significantly delayed the time to recurrence of any mood episode in adults having a manic episode at screening vs placebo.

“The unique attribute of this compound is that it is the only antimanic agent that has been shown to possess efficacy when administered once monthly,” Joseph Calabrese, MD, director of the Mood Disorders Program at University Hospitals Cleveland Medical Center in Ohio, said in an interview with Psychiatry Advisor. “This should be highlighted prominently, as patients frequently forget to take medicine for mania and hypomania when administered by mouth.” Before this approval, patients had access to only 1 other long-acting injectable atypical for the maintenance treatment of BP-I.

Abilify Maintena is a once-a-month injectable formulation for intramuscular use that has already been approved for treatment of schizophrenia in adult patients. Its efficacy, although unknown, may be mediated through a combination of partial agonist activity at dopamine D2 and serotonin 5-HT1A receptors and antagonist activity at 5-HT2A receptors.

The phase 3 study enrolled patients who were experiencing a manic episode at screening and met the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision, criteria for BP-I. “Eligible patients had a history of at least 1 previous manic or mixed episode with manic symptoms of sufficient severity to require 1 of the following interventions: hospitalization and/or treatment with a mood stabilizer, and/or treatment with an antipsychotic agent,” Dr Calabrese stated.

“The label expansion provides healthcare professionals a new treatment option for their patients who have established tolerability with oral aripiprazole,” Dr Calabrese added. “Receiving Abilify Maintena each month as prescribed and administered by a [healthcare provider] provides patients an opportunity to be free from taking their daily antipsychotic for BP-I.” He also noted that concomitant oral antipsychotic must be administered for 14 days after the first injection.

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“Of the 175 patients screened, 731 met eligibility criteria,” Dr Calabrese said. “These patients were then converted to oral aripiprazole and then sequentially stabilized, first on oral aripiprazole and then on Abilify Maintena.

“Of 425 patients who entered the Abilify Maintena stabilization portion of the trial, a total of 266 patients met the stabilization criteria and entered the double-blind randomized withdrawal phase of the study; patients were randomly assigned to Abilify Maintena (400 mg) or placebo,” continued. “Of these, 102 (38.3%) completed the study: 48.1% in the Abilify Maintena group and 28.6% in the placebo group.

Dr Calabrese also noted that the randomized population included patients who had been previously stabilized on Abilify Maintena (400 mg) monotherapy. “The clinical profile of Abilify Maintena might be less robust in a clinical practice setting where patients were not previously exposed to Abilify Maintena or require adjunct treatment in addition to antipsychotics,” he said.


Abilify Maintena® (aripiprazole) for extended-release injectable suspension approved by the U.S. FDA for maintenance monotherapy treatment of bipolar I disorder [news release]. Valby, Denmark, and Tokyo, Japan: Lundbeck; July 28, 2017. http://investor.lundbeck.com/releasedetail.cfm?releaseid=1034936.  Accessed August 7, 2017.